NDAORALCAPSULEPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
7
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SARAFEM is an oral capsule formulation of fluoxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI) approved in 1987 for depression and post-traumatic stress disorder. The drug works by inhibiting CNS neuronal uptake of serotonin, though its precise mechanism remains incompletely understood. It is indicated for adult patients with major depression or PTSD seeking oral pharmacotherapy.
LOE Approaching
Product is in LOE-approaching lifecycle with moderate competitive pressure (45/100), suggesting team focus is on lifecycle extension and brand preservation rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Under Fasting Condition
Started Feb 2006
54 enrolled
Healthy
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed Condition
Started Feb 2006
54 enrolled
Healthy
90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions
Started May 2001
26 enrolled
Healthy
90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions
Started May 2001
26 enrolled
Healthy
To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg
Started Feb 2001
30 enrolled
Depression
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.